Study to Determine the Safety and Efficacy of TANOVEATM (Rabacfosadine for Injection) in Cats with Lymphoma Using a Dose Escalation Model

Study Objective: 

The purpose of this study is to evaluate the safety and efficacy of a new anti-cancer agent in the treatment of cats with lymphoma.  Lymphoma is one of the most commonly diagnosed cancers in cats.  Chemotherapy is the treatment of choice, and multi-agent doxorubicin-containing protocols are often recommended. While this approach has proven successful in inducing clinical remission in dogs, evidence to support its use as “standard of care” in cats is lacking.  TANOVEATM is a novel targeted anti-cancer therapy that has demonstrated significant efficacy in dogs with lymphoid neoplasia.  For the most part, it has been well tolerated, with potential side effects including bone marrow suppression, skin toxicity, and gastrointestinal upset.  TANOVEATM has not been studied in cats with lymphoma.  Cats must have a confirmed diagnosis of lymphoma (any grade, any anatomic site) to be eligible for participation in this study.  In addition the following conditions must be met:

Cats will undergo preliminary staging tests including initial consultation and physical examination, tumor measurements, complete blood count (CBC), serum biochemical profile, urinalysis, and chest x-rays to determine trial eligibility.  Once accepted into the study, the intent will be to administer escalating dosages of TANOVEATM to each cat every 3 weeks for approximately 5 treatments.  Cats will be rechecked one week after first treatment for assessment of adverse events; after the second treatment, they will be seen every 3 weeks for administration of drug.  Lab work will be rechecked prior to each treatment.  Tumor measurement and disease restaging will be strongly encouraged at the time of every other treatment to determine drug efficacy.  Trial participation will continue as long as the treatment is well tolerated and response to treatment is favorable.  Once off study, the cat will be eligible for other treatment as deemed appropriate.

Exclusion Criteria: 
  1. Cats must be FeLV/FIV negative, otherwise healthy, and have adequate bone marrow and organ function.
  2. Prior treatment is acceptable (although not required), but there must be an appropriate lapse between other cytotoxic treatment(s) and trial entry. 
  3. Owners must sign a consent form.

 

Compensation: 
This is a partially funded trial, the rabacfosadine will be provided at no cost to the client. The client will be responsible for all other costs.
Location of Trial: 
Norwalk, CT

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